Lithium Versus Anticonvulsants and the Risk of Physical Disorders

• Sponsor: Mental Health Services in the Capital Region, Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT06005155
• Collaborator: (none)
• Enrollment: 169,285
• Location: 1
• Actual Duration (Months): 13
• Patients Per Site Per Month: 13044.6

Study Details

Study Description

Brief Summary

Nationwide population-based register linkage study covering the entire 5.9 million inhabitants in Denmark systematically investigating the associations between sustained long-term use of lithium versus lamotrigine and valproate, and the risk of a range of physical disorders emulating a randomized trial.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Drug: Lithium

Detailed Description

The study includes two cohorts. Cohort 1: all 12.607 patients with a diagnosis of bipolar disorder (ICD-10 code: DF30-31.9) who subsequently were exposed to either lithium, lamotrigine or valproate between 1997 and 2021. Cohort 2: as Cohort 1, but regardless of prior diagnosis of bipolar disorder (N= 156.678).

Main analyses considered a patient exposed to a drug 92 days after a prescription and a 10-year follow-up and 4 sensitivity analyses considered a patient exposed to a drug for 60 and 180 days after a prescription, respectively, and with 5- and 15-years follow-up, respectively.

Study Design

• Study Type: Observational
• Actual Enrollment: 169285 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Lithium Versus Anticonvulsants and the Risk of Physical Disorders - Results From a Comprehensive Long-term Nation-wide Population-based Study Emulating a Randomised Trial
• Actual Study Start Date: Jun 1, 2022
• Actual Primary Completion Date: Jul 1, 2023
• Actual Study Completion Date: Jul 1, 2023

Outcome Measures

Primary Outcome Measures

1. Incident stroke (separately for intracerebral hemorrhage and cerebral infarction) [1997 to 2021]

   Diagnosis in the Danish National Hospital Register

2. Arteriosclerosis [1997 to 2021]

   Diagnosis in the Danish National Hospital Register

3. Angina pectoris [1997 to 2021]

   Diagnosis in the Danish National Hospital Register

4. Myocardial infarction [1997 to 2021]

   Diagnosis in the Danish National Hospital Register

5. Diabetes mellitus (separately for type 1 diabetes and type 2 diabetes) [1997 to 2021]

   Diagnosis in the Danish National Hospital Register

6. Myxoedema [1997 to 2021]

   Diagnosis in the Danish National Hospital Register

7. Osteoporosis [1997 to 2021]

   Diagnosis in the Danish National Hospital Register

8. Dementia (separately for Alzheimer's disease and other dementia) [1997 to 2021]

   Diagnosis in the Danish National Hospital Register

9. Parkinson's disease [1997 to 2021]

   Diagnosis in the Danish National Hospital Register

10. Chronic kidney disease (definite chronic kidney disease and possible Chronic kidney disease) [1997 to 2021]

    Diagnosis in the Danish National Hospital Register

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• diagnosis of bipolar disorder and subsequent exposure to either lithium, lamotrigine or valproate

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Psychiatric Center Copenhagen	Copenhagen		Denmark	2000

Sponsors and Collaborators

• Mental Health Services in the Capital Region, Denmark

Investigators

• Principal Investigator: Lars V Kessing, Professor, Psychiatric Center Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mental Health Services in the Capital Region, Denmark
• ClinicalTrials.gov Identifier: NCT06005155
• Other Study ID Numbers: Lithium versus anticonvulsants
• First Posted: Aug 22, 2023
• Last Update Posted: Aug 22, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mental Health Services in the Capital Region, Denmark: Lithium; Lamotrigerne; Valproate; Physical disorders
• Additional relevant MeSH terms: Bipolar Disorder; Valproic Acid

Study Results

No Results Posted as of Aug 22, 2023